BrainScope Grand Rounds Series- Publication Navigator

The BrainScope One system provides objective data that helps clinicians answer two key questions in mildly presenting head-injured patients:

1. Is it likely that there is a structural brain injury that would be visible on a CT scan?

2. Is there evidence of functional brain impairment that could indicate a concussion?

The video below highlights a decade worth of research and development of the BrainScope One device. This includes 24 investigator-initiated publications describing clinical usability, the standard of care comparisons, and the validation of the BrainScope One algorithms.

Grand Round Videos Presented By Leslie Prichep, Ph.D Chief Scientific Officer, BrainScope Company Inc. Adjunct Professor, Department of Psychiatry New York University School of Medicine

The following four videos are intended to educate healthcare professionals on the fundamental scientific and clinical basis of the BrainScope One device. They are not intended to be a substitute for device labeling. Please consult with BrainScope for detailed device labeling such as Indications for Use and Instruction / Directions for Use.

BrainScope Grand Rounds Series- Brain Function Index

The video below explains one of two of BrainScope One’s EEG-based brain injury assessment capabilities, the Brain Function Index. The BFI compares the patient’s brain electrical activity to that of a comparable non-injured population to objectively determine the likelihood, and severity, of brain function impairment.

Grand Round Videos Presented By Leslie Prichep, Ph.D Chief Scientific Officer, BrainScope Company Inc. Adjunct Professor, Department of Psychiatry New York University School of Medicine

BrainScope Grand Rounds Series- Structural Injury Classifier

The video below explains one of two of BrainScope One’s EEG-based brain injury assessment capabilities, the Structural Injury Classifier. The SIC provides clinicians with objective results that indicate the likelihood of a structural brain injury being present or visible on a CT Scan.

Grand Round Videos Presented By Leslie Prichep, Ph.D Chief Scientific Officer, BrainScope Company Inc. Adjunct Professor, Department of Psychiatry New York University School of Medicine

Hurt Your Head? How Do You Rule Out A Brain Bleed? Do You Have A Concussion?

BrainScope One is a new, accurate, cost-effective, radiation-free medical device, cleared by the FDA, that offers a full assessment of your head injury. This assessment tool collects objective information right from your brain! BrainScope One answers two important questions for your doctor: Is there a structural injury? Is there a functional abnormality? BrainScope One can assist your physician in making an objective decision on whether to send you to the ER, start treatment for a concussion, or send you home with a clean bill of health. While not a replacement to CT, BrainScope One assessment can be done at a fraction of the cost of a CT, it can be done at your neighborhood doctor’s office, urgent care setting or yes, even in the ER!

Health Beat: BrainScope test for concussion

University linebacker Zane Ventimiglia suffered not one, but two concussions last season. He didn't see either hit coming, but felt them after.

"I remember being pretty off-kilter, not able to balance well," recalled Ventimiglia, 21.

Athletic director Nathan Wilder said right after injury, trainers have to rely partly on subjective tests, like how an athlete looks or says he feels.

"These kids are pretty resilient. They'll take a hit, come off and say they're OK. Then, a couple of minutes later, they're not," Wilder said.

Now, there's a new, portable device designed to give an objective assessment. The BrainScope measures brain waves.

BrainScope Receives $4.5 Million Department of Defense Contract to Add Ocular Assessment to Future Concussion Products

Artificial Intelligence and Multi-Modal Capabilities to Optimize Personalized Concussion Assessment

BETHESDA, MD. September 4, 2018– BrainScope today announced that it has been awarded a research contract by the United States Department of Defense (DOD) valued at $4.5 million to create and integrate ocular capabilities into its handheld, multi-parameter mild Traumatic Brain Injury (mTBI) and concussion products. 

BrainScope’s initial product in the market, BrainScope One, is the first FDA-cleared medical device to offer capabilities to assess the full spectrum of brain injury – from concussions (functional abnormality) to brain bleeds (structural injury) using EEG and other parameters which together provide the clinician a panel of capabilities to help with their clinical diagnosis.  With this research contract, BrainScope will add specific capabilities related to assessment of the patient’s eyes which will be incorporated in future versions of BrainScope’s products.     

BrainScope Receives Prix Galien Award Nomination for Its Concussion and Traumatic Brain Injury Assessment Product

BETHESDA, MD.--(BUSINESS WIRE)--BrainScope today announced its second consecutive nomination for the 2018 Annual Prix Galien USA Awards for “Best Medical Technology” product. Its flagship BrainScope One product is a multi-modal, comprehensive, handheld capability to help clinicians objectively and rapidly assess and triage head injured patients directly at the point of care.

Over 30% Potential Cost Reduction to Payers and Patients through Integration of BrainScope One for Mild Traumatic Brain Injury / Concussion Assessment

An Economic and Actuarial Model Demonstrates Substantial Cost Benefit to Health Insurers and Patients

BETHESDA, MD. June 28, 2018 – BrainScope announced today the release of a white paper which demonstrates a significant positive impact on the costs to the healthcare system from integrating BrainScope One into the assessment of mild traumatic brain injury / concussion. Escalating awareness of the consequences of traumatic brain injury, even when mild, has resulted in an increasing burden to the healthcare system of $76.5 billion annually. Overall findings of the white paper, authored by a well-respected team comprised of an economist and actuaries, demonstrated that the use of BrainScope One in the Emergency Department and Community settings (including Urgent Care Centers) could result in a significant reduction of costs of up to 32.2%. This is accomplished by a combination of diversion from hospital emergency departments to less expensive care settings, as well as a significant reduction in the number of unnecessary CT scans…

Economic Impact on the Healthcare System using an FDA-Cleared Mild Brain Injury/Concussion Assessment Device

Read full white paper here: BrainScope One Economic Analyzer Model White Paper

Abstract

Over 30% Cost Savings to Payers and Patients Calculated from the BrainScope One Economic Analyzer Model (BEAM)

Escalating awareness of the short and long-term consequences of traumatic head injury, even when mild, has resulted in an increasing burden to the health care system to the extent of $76.5 billion annually. This white paper demonstrates potential cost reductions as high as 32.2%, shared between payers and patients when the BrainScope® One medical device is integrated into the patient care pathway.

Adoption of BrainScope One expands care access points for head injury to Urgent Care Centers (UCC) and Physician offices, more cost efficient and accessible environments. It can also improve patient triage in the Emergency Department (ED) by diverting patients from unnecessary CT scans. BrainScope One has been demonstrated to aid in more objective, accurate, rapid, and safer diagnosis of mild Traumatic Brain injury (mTBI/concussion), resulting in significant benefits across the healthcare system. This paper assesses BrainScope One’s impact on the health care system and specifically examines the potential cost savings to patients and payers using the BrainScope Economic Analyzer Model (BEAM). Utilizing realistic inputs, this model illustrates the significant opportunity for cost savings (as high as 32%) through adoption of BrainScope One.

Rockville, Maryland Urgent Care Uses Revolutionary Brain Injury Assessment Device Backed By The NFL To Reduce CT Scan Recommendations

View Original Article on Digital Journal

ROCKVILLE, MARYLAND - Identifying and detecting brain injuries early is paramount for patients as brain damage associated with concussion, stroke, tumors and other illnesses can dramatically compromise a patient's quality of life.

To effectively treat adult patients with a suspected brain injury one urgent care in Rockville, Maryland, Physicians Now, added a groundbreaking medical technology called BrainScope One to their arsenal of diagnostic tools. BrainScope One provides their providers and staff with greater assurance to objectively diagnosis the full spectrum of brain injuries, including concussions.

BrainScope Initiates Teenage and Young Adult Multi-Site Clinical Study for Concussion Assessment Product

BETHESDA, MD May 31, 2018 – BrainScope, a medical neurotechnology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today the initiation of a large, multi-site clinical research study enrolling subjects ages 13-25 years who sustained a head injury from a variety of causes, including sports-related head injuries. Designed as a prospective, observational investigation, eligible patients who sustained a head injury will be recruited from concussion clinics and high schools surrounding the participating universities conducting the study. 

“The initiation of this large clinical study is a significant milestone in the development of BrainScope’s next-generation brain injury assessment products to include teenage patients suspected of a concussion,” said Michael Singer, CEO of BrainScope.“We are aggressively pursuing this very large demographic with plans to introduce a teenage-focused product in the near-term,” stated Singer.

Medics start using scanner that could detect TBI earlier

By J.P. LAWRENCE | STARS AND STRIPES
Published: May 27, 2018
Full Source

AP LIGHTNING, Afghanistan -- Soldiers are trying out a high-tech brain scanner that tests for mild traumatic brain injuries.

The 1st Security Force Assistance Brigade is the first unit to use the smartphone-sized BrainScope device in the field.

Capt. Nicholas Koreerat, a physical therapist in the 1st SFAB, trained newly-arrived medics from the 2nd Squadron (Armored), 1st Cavalry, 4th Infantry Division on the device Saturday at Advising Post Lightning near Gardez.

Prevacus Partners with BrainScope for Upcoming Drug Study on Concussion

TALLAHASSEE, Fla., May 18, 2018 /PRNewswire/ -- Prevacus, Inc., a leading biopharmaceutical company focused on developing treatments for concussion (mild traumatic brain injury (mTBI)) and other neurological disorders today announced a partnership with BrainScope for use of their FDA-cleared BrainScope One device in Prevacus' upcoming Phase 1b clinical research study as an objective biomarker of brain function. Prevacus and BrainScope are supported in their efforts to find a solution to concussions for youth and professional athletes by 3 Super Bowl MVP quarterbacks including Brett Favre, Kurt Warner and Mark Rypien.

Potential to Reduce Emergency Department Referrals From Urgent Care Centers By Up To 75% for Mildly Presenting Head Injured Patients

Read full white paper here: BrainScope One Urgent Care ED Diversion White Paper – May 2018

Abstract
The standard of care today for assessment of traumatic brain injury (TBI) in the Emergency Department (ED) remains the head CT scan, despite the fact that 91% of those scanned are reported to be negative for structural brain injury. Since approximately 95% of head injured patients present as mild, there are a very large number of unnecessary CT scans performed for the mTBI/concussion population. Urgent Care Centers (UCC) have the potential to significantly impact on initial triage and assessment of mild head injured patients, yet today standard clinical assessment capabilities in UCC result in a large percentage of such patients being referred to the ED for CT imaging, most often found to be negative. The ability to objectively assess these patients at the UCC could greatly improve evaluation and care of the mTBI/concussion population. BrainScope One is a novel handheld, rapid, easy to use, FDA cleared medical device to aid in the objective assessment of full spectrum of brain injury, including the likelihood of a structural brain injury visible on CT, with high accuracy shown in a prospective independent FDA validation trial. This White Paper evaluates the reduction of unnecessary UCC referrals to the ED for CTs when BrainScope One was integrated into the clinical decision pathway, based on 196 patients whose data was entered data into the BrainScope One Registry by 12 UCC. Significant reductions in ED referrals were realized (as high as 75%) when BrainScope One was used to aid in referral decisions across a wide range (100% to 50%) of prior clinical practice referral rates, supporting the potential to significantly impact on ED diversion and reduction of unnecessary CT scans in the mild brain injury population, benefiting the patient and reducing costs to the healthcare system.

Using BrainScope One in Urgent Care Centers Shows Potential 75% Reduction in Head Injury Referrals to Emergency Departments

BrainScope One Provides Objective, Actionable Information for Assessment of Mildly Presenting Head Injured Patients in Urgent Care Centers, Emergency Departments, and Other Settings

BETHESDA, MD. MAY 7, 2018 – BrainScope announced today the release of a white paper authored by Urgent Care physicians which demonstrated that the FDA-cleared BrainScope One had the potential to reduce unnecessary Emergency Department referrals by up to seventy-five percent.  BrainScope One offers a rapid (within minutes) assessment of the full spectrum of traumatic brain injury (TBI), including concussion, using digital electroencephalography (EEG) and other modalities, facilitating accurate and timely decision-making for first responders, clinicians, and other health practitioners at the point of care wherever an injury occurs. 

Close to 5 million people who experience a TBI seek care and treatment at hospital Emergency Departments (EDs) in the U.S. each year, where over 80% of these patients are evaluated using a computed tomography (CT) scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment.  Over 90% of these CT scans are found to be negative, unnecessarily exposing patients to radiation, long wait times, and high costs.   

BrainScope One Demonstrated the Potential to Reduce Head CT Scans By One-Third in Emergency Department Use

BETHESDA, MD. APRIL 30, 2018 – BrainScope announced today the release of a white paper authored by physicians at Washington University Barnes Jewish Medical Center in St. Louis, which demonstrated that the FDA-cleared BrainScope One had the potential to reduce the use of unnecessary head CT scans by one-third in a hospital Emergency Department setting.

Today most patients seen in the emergency room with a suspected head injury receive a computed tomography (CT) scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment; however, the vast majority of these patients do not have detectable intracranial lesions visible on the CT scan. The availability of BrainScope One can help health care professionals determine the need for a CT scan and help prevent unnecessary neuroimaging and associated radiation exposure to patients.

Using data entered in BrainScope’s national Registry, the white paper authors compared 64 patients who were referred for CT scan…

Potential Significant Reduction in Unnecessary CT Scans in Emergency Departments Using an FDA Cleared Medical Device for Brain Injury Assessment

Read full white paper here: Washington University Emergency Department White Paper

Abstract:
Despite the fact that most CT scans performed on head injured patients are negative, CT remains the “gold standard” for evaluation of head injury in the Emergency Department.  This study investigates the utility of the BrainScope One EEG based classification algorithm to aid in the reduction of unnecessary CT scans in the mild head injured population.  Evaluations were performed on 64 patients (mean age 43.5, 58% male, 98% GCS=15), enrolled in the BrainScope One Registry, who sustained closed head injury and were evaluated in the ED at Washington University (mean time since injury 10.1 hours) and were referred for CT scans by standard clinical site practice pathway. Results were compared with those from BrainScope One evaluation. In this population of ED patients, the BrainScope One decision pathway would have resulted in a 32.8% reduction in the overall number of CT scans referrals compared to the clinical site practice decision pathway.  Importantly, this reduction in CTs was achieved without incurring any false negative cases (100% sensitivity). 

 

New Tool Takes On Early Detection Of Brain Injuries

Source: http://baltimore.cbslocal.com/2017/09/12/brainscope-brain-injury-tool/

By Alex DeMetrick

BALTIMORE (WJZ) — When it comes to looking for the first signs of concussion or other brain injuries, a new tool is available from a Maryland company — and it’s being backed by the NFL and the Department of Defense.

The device, called BrainScope, comes in two parts. It includes a disposable electrode headset, and a military-grade smartphone with specialized software.

The tool is designed to give an objective appraisal of possible brain injury as early as possible after an accident:

“So much of brain injury assessment is subjective, and so what we are adding is objectivity. You’re literally reading the brain electoral activity of the patient,” says Michael Singer, CEO of BrainScope.

“Close your eyes, relax and keep your feet flat on the floor.”

The software compares activities of an uninjured brain, like relaxing, with the readings of someone who suffered a concussion.

It also compares cognitive functions with tests taken by the patient, which could lead to a CT scan.

“We run multiple tests and that aggregation is what is then used by the clinicians for them to make a diagnosis,” says Singer.

Supporters of Bethesda-based BrainScope include the military, with the defense department providing funding, as well as the NFL, where brain injuries to players have gone from locker room secret to full-blown headlines:

“There’s just no denying a lot of guys out there like me dealing with the stage of brain injury,” says former NFL player Mitch White.

The portability of BrainScope means versatility with FDA approval.

“It’s meant to be anywhere a head injury might occur, so our markets are places like urgent care centers, emergency room departments in hospitals, the military, universities,” says Singer.